Not Applicable
Not Applicable
1. Field of Invention
This invention relates to an improved packaging system, and associated method for packaging a sterilizable item that allows aseptic introduction of a sterile item, particularly one that has been subjected to flash sterilization, into a sterile environment.
2. Description of the Related Art
In both the fields of medical research as well as practical medicine, and particularly the surgical arts, it is well known that maintaining the integrity of a sterile field is of paramount importance. An excellent dissertation of the background of sterile packaging of sterile instruments is set forth in U.S. Pat. No. 5,638,661 which issued to Banks on Jun. 17, 1997. As described by Banks, medical professionals have long recognized the need for maintaining sterile conditions, especially in an operating room. Thus, under standard operating room procedure sterile equipment covers and patient drapes protect and define a sterile surgical field, and all items within the defined surgical field must be sterile.
Such items as equipment covers, patient drapes, and other medical supplies, whether of the single-use variety or reusable, must be sterilized and packaged in a manner that will protect and maintain both the sterility of the item and the sterility of the surgical field during the introduction of the sterile item onto the surgical field. In practice this has meant that many items intended for use in a surgical field are double packaged: a completely sealed outer packaging element surrounds an inner packaging element in or on which the sterilizable item is located. At some point in the production cycle the double-packaged item is sterilized so that when the item arrives at the point of use, both the item and the inner packaging element are sterile.
The inner packaging element is intended to provide a second level of protection and to maintain the sterility of the item and of the sterile field during introduction of the item onto the sterile field. An example of a typical inner packaging element is a sheet of material folded in a so-called central supply wrap (CSR), a name that originally identified a hospital central supply department as the source of the packaged item. The name now designates a particular type of an envelope fold. And, the Banks patent discloses a packaging system for, and a method for, packaging a sterile item in a manner that preserves both the sterility of the sterilized item and the integrity of the sterile field. Other devices typical of art of packaging sterilizable items are those disclosed in the following U.S. Letter Patents:
Banks discloses a packaging system for a sterilizable item that includes an inner packaging element defined by a sterilizable flexible tubular member having a closed end and an open end. According to Banks, the sterilizable item is placed into the tubular member so that the item contacts a portion of an inside surface at the closed end of the tubular member. A border portion is formed on the tubular member so that a first edge of the border portion is attached to the tubular member proximate the opening of the tubular member for the circumference of the opening and a second opposing edge is spaced apart from the first edge by the width of the border portion. The border portion is preferably formed on the tubular member by folding over a circumferential cuff so that a first portion of an outside surface of the tubular member contacts a second portion of the outside surface. In use, a non-scrubbed attendant holds the closed end of the tubular member. With a second hand, the attendant grasps the edge of the border portion at the side of the item. The attendant pulls on the edge of the border portion, at alternate sides of the item, until the tubular member has been inverted to expose generally the entire inside surface of the tubular member, while in the process covering the attendant""s hand and forearm with the inverted tubular member. With hand and forearm thus covered and protected, the non-scrubbed attendant may aseptically place the item directly onto the sterile surgical field, eliminating the need for a scrubbed assistant. However, because the tubular member is only a single ply, there is an inherent risk of compromising the sterility of the item, and the sterile field. In this regard, if there is any slight tear or rip in the portion of the tubular member encompassing the sterilized item, and the attendant""s hand touches the sterile item, the item has been contaminated. Of course, if the attendant is unaware of the contamination and introduces the item onto the sterile field, the entire field has been contaminated.
An additional problem associated with sterile packaging typified by the Banks patent, and by the invention disclosed in my co-pending application, is encountered when items are flash sterilized and immediately delivered from the sterilizer into the sterile field. In this instance, any sterilization wrap, whether woven or non-woven, is undesirable due to the presence of moisture which provides a strike through path for contaminants due to the porosity of the wrap material.
Accordingly, there is a need for a package for receiving a sterilizable item that allows the item to be introduced into a sterile field by a non-sterile attendant without contaminating the sterile field and that eliminates the strike through path for contaminants in a sterile package that has been flash sterilized.
It is therefore an object of the present invention to provide a packaging system, and associated method, for packaging a sterile item for sterile introduction of the item into a sterile field.
A further object of the present invention is to provide a reinforced package that protects the item, and the sterile field into which it will be introduced, from inadvertent contamination.
Still another object of the present invention is to provide a reinforced package that can be flash sterilized without providing a strike through path for contaminants.
Other objects and advantages over the prior art will become apparent to those skilled in the art upon reading the detailed description together with the drawings as described as follows.
In accordance with the teachings of the present invention a package for a sterilizable item is provided. The package includes a tubular member having an open end and a closed end. A reinforcing panel encompassing the closed end is secured to the tubular member proximate the closed end such that the reinforcing panel includes an open end. A cuff portion is attached to the tubular member proximate the open end of the tubular member. The cuff portion includes a first edge secured to the tubular member and a second edge in spaced relation from the first edge, wherein in the cuff portion extends from the open end of the tubular member and substantially overlaps the open end of said reinforcing panel. A portion of the inside surface of the tubular member is thus exposed and defines the width of the cuff portion. In the preferred embodiment, the cuff portion is integral with the tubular member. In this regard, the cuff portion is preferably formed on the tubular member by folding over a circumferential cuff so that a first portion of an outside surface of the tubular member contacts a first portion of the outside surface of the reinforcement panel. A portion of the inside surface of the tubular member is thus exposed and defines the width of the cuff portion.
In addition, an autoclavable moisture barrier is bonded to the reinforcement panel. In this regard, the moisture barrier begins at the closed end along and extends along a portion of the reinforcement panel. The moisture barrier provides a non-porous layer that eliminates a moisture path through the material after the package has been flash sterilized. The reinforcement panel provides a buffer layer between an attendant""s grasping hand (not shown) and an item placed within the tubular member such that the attendant""s hand is not in direct contact with the layer of material of the tubular member that is in contact with the item. In this manner, an item that has been flash sterilized in the package of the present invention can be delivered into a sterile field, by a non-sterile attendant, without creating a risk